EN 1642:2009
(Main)Dentistry - Medical devices for dentistry - Dental implants
General Information
- Abstract
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
- Status
- Withdrawn
- Publication Date
- 27-Oct-2009
- Withdrawal Date
- 18-Oct-2011
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55/WG 7 - Steering Committee
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 19-Oct-2011
- Completion Date
- 19-Oct-2011
- Directive
- Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 183 OJ Date: 07-Jul-2010
Relations
- Effective Date
- 31-Oct-2009
- Effective Date
- 08-Oct-2011
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Frequently Asked Questions
EN 1642:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Medical devices for dentistry - Dental implants". This standard covers: This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
EN 1642:2009 is classified under the following ICS (International Classification for Standards) categories: 11.060.15 - Dental implants. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1642:2009 has the following relationships with other standards: It is inter standard links to EN 1642:2004, EN 1642:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1642:2009 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1642:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.LPSODQWDWLZahnheilkunde - Medizinprodukte für die Zahnheilkunde - DentalimplantateArt dentaire - Dispositifs médicaux pour l'art dentaire -Implants dentairesDentistry - Medical devices for dentistry - Dental implants11.060.15Zobni implantatiDental implantsICS:Ta slovenski standard je istoveten z:EN 1642:2009SIST EN 1642:2010en,de01-januar-2010SIST EN 1642:2010SLOVENSKI
STANDARDSIST EN 1642:20051DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1642
October 2009 ICS 11.060.15 Supersedes EN 1642:2004English Version
Dentistry - Medical devices for dentistry - Dental implants
Art dentaire - Dispositifs médicaux pour l'art dentaire -Implants dentaires
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Dentalimplantate This European Standard was approved by CEN on 19 September 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1642:2009: ESIST EN 1642:2010
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 10Bibliography . 11 SIST EN 1642:2010
1) Addition of new relevant product standards, issued after 2004: EN 1641, EN ISO 11135-1,
EN ISO 11137-1, EN ISO 11607-1, EN ISO 11607-2, EN ISO 14801, EN ISO 14971, EN ISO 22794,
EN ISO 22803; 2) Deletion of the following withdrawn standards: EN 550, EN 552, EN ISO 14727; b) 4.5 Clinical evaluation: Clarification of requirement for a clinical evaluation; c) 4.6.4 Instructions for use: Clarification of requirement that information may be provided in an electronic format; d) Annex ZA: Actualisation of correspondence between this European Standard and Directive 93/42/EEC, as amended by Directive 2007/47/EC. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
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